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Testosterone Replacement, Low T, HCG, & Beyond
Testosterone Basics & Questions
New Member Question Re "Standard Range=86.98 - 780.10 ng/dL"?
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<blockquote data-quote="Mr. Clark" data-source="post: 195072" data-attributes="member: 41940"><p>Thanks.</p><p></p><p>I'm not sure what lab was used. They drew blood at his office a couple weeks ago, and I received the test results in a message on my doctor's website later the same day. It did not specify a lab. Given that the "Standard Range" listed in the message is identical to the results listed in the DHHS's letter of 6/29/16 to Matthew Gee of Siemens concerning the Section 501(k) notice filed by Siemens, I'm assuming the lab used the Siemens test kit.</p><p></p><p>One thing that strikes me as somewhat odd is that the letter of 6/29/16 from DHHS to Siemens lists a device number of K151986. A letter from the FDA to Siemens dated 9/20/19 for a "re-standardized" ADVIA Centaur Testosterone (II) TSTII) test (K191533)(see <a href="https://www.accessdata.fda.gov/cdrh_docs/pdf19/K191533.pdf" target="_blank">https://www.accessdata.fda.gov/cdrh_docs/pdf19/K191533.pdf</a>) includes "New Reference Intervals." It appears to me that the new criteria for Reference Intervals (CLSI guideline EP28-A3c) are based on the middle 90% rather than the middle 95%. The table at page 12 of the FDA letter shows a middle 90% range for men 50 and over of 187.72ng/dL - 684.19ng/dL.</p><p></p><p>The Conclusions portion of the FDA letter dated 9/22/19 states:</p><p></p><p>"Based on the results of comparative testing, the re-standardized ADVIA Centaur®Testosterone II (TSTII) is substantially equivalent in principle and performance to the currently-marketed predicate device, the ADVIA Centaur® Testosterone II (TSTII) cleared under 510(k) K151986.</p><p></p><p>The ADVIA Centaur® SHBG <u><strong>with the new reference intervals in the Instructions for Use (package insert)</strong></u> is substantially equivalent to the currently marketed ADVIA Centaur® SHBG (K151986). <strong><u>The new reference intervals that will replace the current reference intervals in the Instructions for Use (Package Inserts)</u></strong> for the currently marketed assay do not require collection of additional analytical performance data." (emphasis added)</p><p></p><p>In other words, if my doctor used the new reference intervals <em>for the exact same test</em> with a lower end of 187.72ng/dL I would meet the criteria. </p><p></p><p>I strongly suspect that the lab uses software to generate the test results, and the lab probably failed to update the reference intervals in the software consistent with the package inserts for the new test kits.</p><p></p><p>Regardless, I find the situation annoying. I'm not a doctor, but it seems to me a doctor should do more than run tests and base decisions very strictly on whether or not the test results fall in the bottom 2.5% or top 2.5% of a group of 137 men across an age range of 39 years (50-89). </p><p></p><p>I find myself wondering if this automated approach is due to an honest belief that this is best, or if it's driven by pressure from insurance companies, fear of state medical licensing agencies, or a fear of malpractice liability for deviating from a strict numbers-based approach.</p></blockquote><p></p>
[QUOTE="Mr. Clark, post: 195072, member: 41940"] Thanks. I'm not sure what lab was used. They drew blood at his office a couple weeks ago, and I received the test results in a message on my doctor's website later the same day. It did not specify a lab. Given that the "Standard Range" listed in the message is identical to the results listed in the DHHS's letter of 6/29/16 to Matthew Gee of Siemens concerning the Section 501(k) notice filed by Siemens, I'm assuming the lab used the Siemens test kit. One thing that strikes me as somewhat odd is that the letter of 6/29/16 from DHHS to Siemens lists a device number of K151986. A letter from the FDA to Siemens dated 9/20/19 for a "re-standardized" ADVIA Centaur Testosterone (II) TSTII) test (K191533)(see [URL]https://www.accessdata.fda.gov/cdrh_docs/pdf19/K191533.pdf[/URL]) includes "New Reference Intervals." It appears to me that the new criteria for Reference Intervals (CLSI guideline EP28-A3c) are based on the middle 90% rather than the middle 95%. The table at page 12 of the FDA letter shows a middle 90% range for men 50 and over of 187.72ng/dL - 684.19ng/dL. The Conclusions portion of the FDA letter dated 9/22/19 states: "Based on the results of comparative testing, the re-standardized ADVIA Centaur®Testosterone II (TSTII) is substantially equivalent in principle and performance to the currently-marketed predicate device, the ADVIA Centaur® Testosterone II (TSTII) cleared under 510(k) K151986. The ADVIA Centaur® SHBG [U][B]with the new reference intervals in the Instructions for Use (package insert)[/B][/U] is substantially equivalent to the currently marketed ADVIA Centaur® SHBG (K151986). [B][U]The new reference intervals that will replace the current reference intervals in the Instructions for Use (Package Inserts)[/U][/B] for the currently marketed assay do not require collection of additional analytical performance data." (emphasis added) In other words, if my doctor used the new reference intervals [I]for the exact same test[/I] with a lower end of 187.72ng/dL I would meet the criteria. I strongly suspect that the lab uses software to generate the test results, and the lab probably failed to update the reference intervals in the software consistent with the package inserts for the new test kits. Regardless, I find the situation annoying. I'm not a doctor, but it seems to me a doctor should do more than run tests and base decisions very strictly on whether or not the test results fall in the bottom 2.5% or top 2.5% of a group of 137 men across an age range of 39 years (50-89). I find myself wondering if this automated approach is due to an honest belief that this is best, or if it's driven by pressure from insurance companies, fear of state medical licensing agencies, or a fear of malpractice liability for deviating from a strict numbers-based approach. [/QUOTE]
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Testosterone Replacement, Low T, HCG, & Beyond
Testosterone Basics & Questions
New Member Question Re "Standard Range=86.98 - 780.10 ng/dL"?
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